Bioinjection device having a tip with a plurality of directional dispersion apertures

ABSTRACT

The bioinjection device has a housing including a pistol grip and an elongated barrel. A trigger is pivotally mounted to the housing. An inner shaft having a distal end is slidable between a first position in which the distal end of the inner shaft is disposed in the barrel and a second position in which the distal end of the inner shaft extends past an opening in the end of the barrel. A tip containing a medicament is disposed about the opening of the elongated barrel. The tip includes at least one aperture for dispensing the medicament. One can inject the medicament from the tip into a bone fracture or degenerative bone tissue during surgery by actuating the trigger of the bioinjection device. A configurable tip may be employed to control the amount and direction of dispersion of such medicament.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/663,476, filed Jul. 28, 2017; which is a continuation of U.S. patentapplication Ser. No. 14/060,484, filed Oct. 22, 2013; which is acontinuation-in-part of U.S. patent application Ser. No. 13/708,772,filed Dec. 7, 2012, now U.S. Pat. No. 8,968,235, issued Mar. 3, 2015,entitled BIOINJECTION DEVICE; which is a continuation of U.S. patentapplication Ser. No. 12/901,208, filed Oct. 8, 2010, now U.S. Pat. No.8,328,753, issued Dec. 11, 2012, entitled BIOINJECTION DEVICE; which isa continuation of U.S. patent application Ser. No. 12/458,779, filedJul. 22, 2009, now U.S. Pat. No. 7,824,359, issued Nov. 2, 2010,entitled BIOINJECTION DEVICE; which claims the benefit of U.S.Provisional Patent Application Ser. No. 61/129,849, filed Jul. 24, 2008,the contents of which are incorporated herein by reference in theirentirety.

COPYRIGHT NOTICE

A portion of the disclosure of this patent document contains materialthat is subject to copyright protection. The copyright owner has noobjection to the facsimile reproduction by anyone of the patent documentor the patent disclosure, as it appears in the Patent and TrademarkOffice patent files or records, but otherwise reserves all copyrightrights whatsoever.

FIELD OF THE INVENTION

The present invention relates to devices for the delivery ofpharmaceuticals, and particularly to a bioinjection device fordelivering bone morphogenic protein, antibiotics, etc., directly to thesite of a bone fracture, degenerative bone tissue or cartilage, etc.,during the course of surgery in the form of a bioabsorbable matrixenclosed within a membrane cartridge.

DESCRIPTION OF THE RELATED ART

Bone is a living tissue and plays a structural role in the body. Diseaseand damage, however, is often difficult to treat in bones, due to theirpositioning within the soft tissues of the body. Bone consists ofrepeating Haversian systems (concentric layers of lamellae depositedaround a central canal containing blood vessels and nerves). The centralcanal is also known as the medullary cavity and is filled with bonemarrow. Within the shaft of a long bone, many of these Haversian systemsare bundled together in parallel, forming a type of bone called compactbone, which is optimized to handle compressive and bending forces. Insome bones, such as the metacarpals, for example, the bones themselvesare hollow and contain little, if any, marrow. Near the ends of thebones, where the stresses become more complex, the Haversian systemssplay out and branch to form a meshwork of cancellous or spongy bone.Compact bone and cancellous bone differ in density, or how tightly thetissue is packed together.

Genetic or developmental irregularities, trauma, chronic stress, tumors,and disease can result in pathologies of bones. Some bone diseases thatweaken the bones include, but are not limited to, osteoporosis,achondroplasia, bone cancer, fibrodysplasia ossificans progressiva,fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesisimperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease,and scoliosis. Weakened bones are more susceptible to fracture, andtreatment to prevent bone fractures becomes important. Severe fractures,such as those that are open, multiple, or to the hip or back, aretypically treated in a hospital. Surgery may be necessary when afracture is open, severe, or has resulted in severe injury to thesurrounding tissues. Severe fractures may require internal devices, suchas screws, rods, or plates, to hold the bone in place or replace lostbone during the healing process.

In order to repair severe fractures, bone cement and the like is oftenapplied within the fracture. However, other healing agents, such asantibiotics or bone morphogenic proteins, often need to be applied priorto cementing or performance of other operations on the bone. Due to theawkward positioning of bone fractures within other tissue, it is oftenquite difficult to properly apply medicaments and the like within thebone, particularly without damaging the tissue surrounding the bone.Thus, a bioinjection solving the aforementioned problems is desired.

SUMMARY

The bioinjection device is directed towards a device for injecting orimplanting a membrane-encased cartridge of pharmaceuticals and/orbiologics, bone grafts, radioactive seeds and the like, in abioabsorbable matrix or carrier directly into the site of a bonefracture, degenerative bone tissue or cartilage, or the like in thecourse of surgery. The cartridge may contain bone morphogenic protein,antibiotics, bone, bone substitute or the like.

The device includes a housing having an upper portion and a lowergripping portion. The lower gripping portion may be rotatable withrespect to the upper portion and includes a handle member and a triggermember. The trigger member is pivotally secured to the handle member.Further, the upper portion of the housing has an open interior regionformed therein.

A shaft is slidably mounted within the open interior region of the upperportion of the housing. The shaft has opposed forward and rear ends andis elongated along a longitudinal axis. Further, the shaft has a channelformed therethrough, also extending along the longitudinal axis from theforward end to the rear end.

At least one lever arm is pivotally mounted within the housing, with theat least one lever arm having opposed first and second ends. The firstend of the lever arm is attached to the rear end of the shaft, and thesecond end is attached to the trigger member so that rotation of thetrigger member with respect to the handle member drives slidingtranslation of the shaft with respect to the upper portion of thehousing.

A needle is slidable within the channel formed through the shaft, theneedle having opposed front and rear ends. The front end of the needleterminates in a relatively sharp point. The rear end thereof is attachedto the at least one lever arm so that rotation of the trigger memberwith respect to the handle member drives forward sliding translation ofthe needle with respect to the upper portion of the housing and theshaft. Preferably, the at least one lever arm includes a pair of leverarms, including a first lever arm driving movement of the shaft and asecond lever arm driving movement of the needle.

A retaining member has opposed front and rear ends. The front end isopen and the rear end is attached to a forward portion of the upperportion of the housing. An opening is formed through the rear end of theretaining member and the forward portion of the upper portion so thatthe forward end of the shaft and the front end of the needle selectivelyand slidably project therethrough into an open interior region of theretaining member. The retaining member is preferably releasably attachedto the forward portion of the upper portion of the housing.

A cartridge is releasably received within the open interior region ofthe retaining member. The cartridge includes an outer shell membrane anda medicament contained within the outer shell. The forward end of theshaft contacts the membrane so that actuation of the trigger membercauses the shaft and the needle to slide forward, with the shaft pushingthe cartridge out of the retaining member for deployment thereof intothe bone fracture. As the shaft pushes the implant out of the retainingmember, the needle pierces the outer shell membrane to release themedicament into the fracture or degenerative tissue.

In another embodiment, a bioinjection device may include a housinghaving a handle member and an elongated barrel connected to the handlemember. The elongated barrel includes a channel and a distal enddefining an opening. A trigger is pivotally mounted on the housing ofthe device. Also, an inner shaft having an end portion (blunt, rounded,or pointed end) is received within the channel of the elongated barrel.The inner shaft is slidable along the channel of the elongated barrelbetween a first position in which the end portion of the inner shaft isretracted within the elongated barrel and a second position in which theend portion of the inner shaft extends past the opening at the distalend of the elongated barrel. The bioinjection device of this embodimentalso includes a tip containing a medicament disposed about the openingat the distal end of the elongated barrel. The tip may include oneaperture or opening for dispensing the medicament, and the tip mayinclude a plurality of apertures or openings. A spring-loaded actuationmechanism couples the trigger with the inner shaft to force medicamentcontained in the tip through the aperture of the tip into a body tissuewhen the trigger is actuated.

In one embodiment, the bioinjection device may include a directionalcontrol member that is operative to selectively control the amount ofdispersion of medicament from one or more of the plurality of tipapertures. The directional control member may be rotatable to close atleast one aperture while leaving at least one aperture in an openposition for dispensing the medicament. Also, the directional controlmember may be used to control the location or angle of dispersion of themedicament from the tip into the body tissue.

It has been contemplated that the tip of the bioinjection deviceincludes apertures that are located equal-distant about thecircumference of the tip. The positioning of the apertures may belocated anywhere along the circumference of the tip or at the distal endof the tip. Further, the tip apertures may have a diameter of about 10millimeters to about 17 millimeters. The tip apertures may also be about5 millimeters in length. Also, tip apertures may vary in size, one fromthe other. The shape of the tip apertures may also vary, one from theother. In other embodiments, the tip apertures are all of the same shapeand size.

The tip may be removably attached to the bioinjection device, andtherefore, one tip may be replaced with a different tip having differentapertures, structures, or medicament. Further, the medicament can beprepared to a desired specification during a procedure and placed withina tip to be used with the bioinjection device. The medicament may becomprised of autograft, allograft, or BMP.

In yet another embodiment, the tip of the bioinjection device may haveapertures that are in an initially sealed state. In use, one of more ofthe apertures can subsequently be opened by a user of the bioinjectiondevice to control the direction of dispersion of the medicament throughone or more apertures located on the tip. More specifically, theapertures may be selectively opened, perforated, or removed to controlthe direction or angle of medicament dispersion from the tip of thebioinjection device. The apertures may be sealed using foil, plastic,silicon, polymers, acrylics, or metal strips.

These and other features of the present invention will become readilyapparent upon further review of the following specification anddrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an environmental, perspective view of a bioinjection device;

FIG. 2 is a side view of the bioinjection device, broken away andpartially in section to show details thereof;

FIG. 3 is a perspective view of a membranous cartridge for use with abioinjection device;

FIG. 4 is a partial side view in section of the bioinjection device,showing a cartridge extended from the device for injection orimplantation;

FIG. 5 is a side view of a plurality of removable and fillable heads ofa bioinjection device according to the present invention;

FIG. 6A is a perspective view of an alternative embodiment of thebioinjection device;

FIG. 6B is a perspective view of another alternative embodiment of thebioinjection device;

FIG. 7 is an exploded view of a plurality of alternative bone implantsfor use with the bioinjection device;

FIG. 8 is a front view of a human leg broken away to show the boneimplants of FIG. 7 inserted within a channel formed within a bone;

FIG. 9 is a side view of an alternative embodiment of the head of thebioinjection device;

FIG. 10 is a side view of another alternative embodiment of thebioinjection device;

FIG. 11A is a side view of one embodiment of a tip or cartridge for usewith a bioinjection device;

FIGS. 11B-11E are cross sectional views taken from line 11B-11B showingdifferent arrangements of apertures in the tip or cartridge;

FIGS. 12A-12C show one embodiment of a tip or cartridge having adirectional control member that can close, open, or partially open oneor more apertures on the tip or cartridge;

FIGS. 13A-13C show another embodiment of a tip or cartridge having adirectional control member that can close, open, or partially open oneor more apertures located on the distal end of the tip or cartridge;

FIGS. 14A-14C are side views of another embodiment of a tip or cartridgehaving a sliding member that can close, open, or partially open one ormore apertures on the tip or cartridge;

FIGS. 15A-15B are side views of yet another embodiment of a tip orcartridge with an aperture that is closed with a sealing member that canbe removed;

FIG. 16 is a side view of an alternative embodiment of a bioinjectiondevice; and

FIG. 17 is an enlarged view of the distal end of the bioinjection deviceshown in FIG. 16.

Similar reference characters denote corresponding features consistentlythroughout the attached drawings.

DETAILED DESCRIPTION

The present invention relates to a bioinjection device 10. As shown inFIG. 1, device 10 is used to place a cartridge 12 into a fracture,degenerative tissue, or the like of a spinal segment S. The cartridge 12contains a medicament (bone morphologic protein, antibiotics, or thelike disposed in a bioabsorbable matrix or carrier) for the healing ofthe spinal segment S. It should be understood that spinal segment S,having vertebral bodies V, disc D and facet joint F, of FIG. 1 is shownfor exemplary purposes only and is not intended to limit the type ofbone or fracture that the cartridge 12 and device 10 may be used totreat.

As best shown in FIGS. 1 and 2, the device 10 includes a housing 32having a barrel-shaped upper portion 33 and a lower gripping portion 35.The lower gripping portion 35 may be rotatable with respect to the upperportion 33 and includes a pistol grip handle member 34 and a triggermember 36. The trigger member 36 is pivotally secured to the handlemember 34 by a pivot pin 39 or the like. Trigger member 36 preferablyhas a plurality of finger receiving grooves or recesses 38 formedtherein, as shown in FIG. 2, allowing for optimal gripping and actuationby the surgeon. Further, an upper gripping handle 11 may be mounted onan upper surface of housing 32, allowing the surgeon to better grip andsecure tool 10 during the surgical operation.

As noted above, the lower portion 35, including both handle member 34and trigger member 36, may be rotatable about pivot 37, allowing thelower gripping portion 35 to be rotated if necessary, depending upon thenature of the particular operation. The lower portion 35 may further beselectively locked in place with respect to the upper portion 33.Further, as shown in FIG. 2, the barrel-shaped upper portion 33 ofhousing 32 has an open interior region formed therein.

As shown in FIG. 2, a shaft 16 is slidably mounted within the openinterior region of the upper portion 33 of the housing 32. The shaft hasopposed forward and rear ends 21, 22, respectively, and is elongatedalong a longitudinal axis, as shown. Further, the shaft 16 has alongitudinally extending channel 25 formed therethrough, extending fromthe forward end 21 to the rear end 22. Shaft 16 is preferablyresiliently or spring-biased with respect to housing 32. In thepreferred embodiment, a stop 13, such as a disc, is mounted to a centralportion of shaft 16, as shown in FIG. 2, with a spring 20 or otherresilient element being biased between the stop 13 and the inner wall offorward portion 50 of housing 32.

At least one lever arm is pivotally mounted within housing 32 for theactuation of shaft 16. Preferably, the at least one lever arm includes apair of lever arms with a first lever arm 28 driving movement of theshaft 16, and a second lever arm 26 driving movement of needle 18, aswill be described in greater detail below. First lever arm 28 hasopposed first and second ends, with the first end of first lever arm 28being secured to the rear end 22 of shaft 16, and the second end beingsecured to the trigger member 36 so that rotation of the trigger member36 with respect to the handle member 34 drives sliding translation ofthe shaft 16 with respect to the upper portion 33 of the housing 32.

Needle 18 is slidably received within the channel 25 formed through theshaft 16, with the needle 18 having opposed front and rear ends 27, 29,respectively (the front end or tip 27 of needle 18 is best shown in FIG.4). The front end 27 of needle 18 is preferably formed as a relativelysharp point. The rear end 29 of needle 18 is secured at 24 to the secondlever arm 26 so that rotation of trigger member 36 with respect to thehandle member 34 drives forward sliding translation of the needle 18with respect to the upper portion 33 of the housing 32 and also withrespect to the shaft 16; i.e., actuation of trigger member 36 causesforward sliding of shaft 16 within the housing 32 and also forwardsliding of needle 18 within the shaft 16.

A retaining member 14 is further provided, with the retaining memberhaving opposed front and rear ends. As shown, retaining member 14preferably forms a pair of gripping jaws for releasably holding implant12. The front end thereof is open and the rear end thereof is secured tomounting member 52, which is fixed to a forward portion 50 of the upperportion 33 of the housing 32. The rear portion of retaining member 14 ispreferably releasably attached to the mounting member 52 through use ofany suitable releasable fastener. The rear portion may have threads 58formed thereon, as best shown in FIG. 4, for reception by a threadedrecess 53 formed in mounting member 52.

Further, an opening 19 is formed through the rear end of the retainingmember 14, and a passage 17 is formed through the forward portion 50 ofhousing 32 so that the forward end 21 of shaft 16 and the front end 27of the needle 18 selectively and slidably project therethrough into anopen interior region of the retaining member 14.

Cartridge 12 is releasably received within the open interior region ofthe retaining member 14. As best shown in FIG. 3, the cartridge 12includes an outer shell membrane 40 and a medicament 42 contained withinthe outer shell 40. The medicament 42 may be a bone morphogenic protein,bone void filler, an antibiotic, or any other desired medicament for thehealing of the bone, and may be disposed in a bioabsorbable matrix orcarrier. The outer shell may be formed from hydroxyapatite calciumphosphate, or any other biodegradable material that will dissolve and/orfuse within the bone. Preferably, the rear end 46 of shell 40 is formedas a relatively thin membrane that can be pierced by tip 27 of needle18. A further thin membrane 44 may be formed between the outer shell 40and the medicament 42.

In use, the cartridge 12 is positioned within retaining member 14, asshown in FIG. 2, with the forward end 21 of shaft 16 contacting the rearsurface 46 of the bone implant 12. Actuation of trigger member 36 causesthe shaft 16 and the needle 18 to slide forward. Retaining member 14 ispreferably formed from a flexible material, such as rubber, plastic orthe like, so that forward movement of shaft 16 pushes the cartridge 12out of the open front end of the retaining member 14 for deploymentthereof into the bone fracture or other damaged or diseased area. As theshaft 16 pushes the cartridge 12 out of the retaining member 14, the tip27 of needle 18 pierces the thin membrane 46 to release the medicament42 into the fracture. The surgeon lodges the pierced cartridge 12 withinfracture F or the degenerative bone tissue.

In FIG. 9, retaining member or head 14 of FIG. 4 has been replaced by analternative head 214, having a rear portion 216 with threads 258,similar to threaded connection 58 of FIG. 4. A pair of spring-biasedjaws 218 are mounted to the rear portion 216, with one or both of thejaws 218 being adapted for releasably gripping a bone dowel 220 or thelike for insertion into a facet joint FJ. In the embodiments of FIGS. 2and 9, the heads 14, 214 and the shaft have relatively small sizes,allowing for placement within the facet joint, as noted above. However,it should be understood that the head and/or shaft might have anysuitable size, dependent upon the site for placement of the cartridge.As will be described in detail below, a longer shaft and head may benecessary for injection of cartridges within a larger or longer bone,such as a tibia, and the shaft and head may be appropriately sizeddependent upon the intended injection site.

FIG. 6A illustrates an alternative embodiment of the bioinjectiondevice. Bioinjection device 100 includes a housing 132 having upper andlower portions 133, 135, similar to that of the embodiment of FIGS. 1-4.Similarly, the lower portion 135 includes a handle member 134 and atrigger member 136, and the upper portion 133 has a handle 111 mountedthereon. Side handles 115 may also be mounted to upper portion 133, asshown, offering the surgeon a variety of gripping surfaces for differingangles of insertion during an operation. In the embodiment of FIG. 6A,an elongated tube 114 is mounted to the front end of barrel-shaped upperportion 133, allowing for the implanting of bone implants whereimmediate proximity of the surgeon's hands is not possible, such as inthe implantation of implants 112 within channel C formed in tibia T ofFIG. 8.

The elongated tube 114 includes an adjustable portion 126, allowing forangular adjustment of the tube 114 adjacent the front end of the upperportion 133 of housing 132. Adjustable portion may be a rotating andselectively locking disc member, as shown, or may be any other suitableangular adjustment device. A central region 128, preferably being solidand relatively non-flexible, is joined to the flexible portions 126 atone end thereof, and a head 120 is disposed at the other end of tube114. Head 120 has an open outer end with external threads 124 formedtherearound.

The retaining jaws 14 of the embodiment of FIGS. 1-5 are replaced inFIG. 6A by a cylindrical retaining member 130 having opposed open ends.Retaining member 130 is formed from a resilient, flexible material,similar to that described above with regard to jaws 14. Internal threads140 are formed in one end of the retaining member 130 for releasableattachment to the head 120 via engagement with threads 124. It should beunderstood that retaining member 130 may be releasably secured to head120 through any suitable releasable fastener.

An implant 112 is received within retaining member 130 for selectivedispensing thereof. Similar to that described above with regard to theembodiment of FIGS. 1-5, an inner shaft 116, similar to shaft 16,extends through tube 114 and is shown in FIG. 6A slightly projectingfrom head 120. Shaft 116 preferably has a plunger-type shape, as shown,with a relatively wide outer face for pushing the wider implant 112. Aneedle 118, similar to needle 18, is housed within shaft 116. Thealternative embodiment of FIG. 6B is substantially similar to that shownin FIG. 6A, but shaft 116 terminates in a covering head 117, whichcovers and surrounds the needle 118 and prevents the needle 118 frombecoming caught in the implant 112. In operation, the user actuatestrigger 136 to slide the shaft 116 and needle 118 forward so that theshaft 116 pushes the implant 112 out of retaining member 130 and needle118 pierces the implant 112, as described above. When retaining member130 is fixed to head 120, the head of plunger 116 will project out fromretaining member 130 (when the trigger is compressed) by approximatelyone or two mm.

Implant 112 is preferably formed from materials similar to thosedescribed above with reference to implant 12. However, as best shown inFIG. 7, implant 112 preferably includes an upper projecting member 113and a lower recess 119. As shown in FIG. 7, multiple implants 112 may bestacked through insertion of an upper projecting member 113 into a lowerrecess 119 of an adjacent implant.

As shown in FIG. 5, the removable retaining members 130 may be storedand filled within a tray 54. In order to allow for quick insertion andreplacement of cartridges 112, cartridges 112 may be positioned withinretaining members 130, as shown. Tray 54 preferably includes a pluralityof channels 56 for filling of cartridges 112 within the stored retainingmembers 130. A syringe 62 or other supply of medicament may be appliedto ports 60, which cover and seal channels 56, allowing the medicamentto be transferred to the cartridges 112. Communication with, and fillingof, cartridges 112 may be accomplished through any suitable fluidtransfer mechanism.

FIG. 8 illustrates this stacked implantation within a channel C formedwithin an exemplary tibia T. Such channels C are often formed from thetalus to the knee during the implantation of rods and the like in tibialreconstruction. The device 100 of FIG. 6 allows for easy insertion ofmultiple implants 112 within channel C after removal of such a rod.

In the alternative embodiment of FIG. 10, device 200 allows for manualinsertion and operation of the implant 112. A gripping handle portion204 is secured to a lower surface of mount 202. Hollow insertion tube206 is mounted on a front portion of the upper surface of mount 202, asshown. The rear portion of the upper surface of mount 202 may have agroove, ridge or other means for slidably holding implant 112. A plunger208 is provided, with plunger 208 having a gripping, rear portion and afront portion terminating in a plunger head 210, with needle 212 beingpositioned centrally therein. In operation, the user loads an implant112 onto the rear, upper surface of mount 202, as shown, and pushesimplant 112 through tube 206, for insertion, with plunger head 210pushing implant through tube 206 and needle 212 piercing the rear end ofimplant 112, as described above.

In another embodiment, a cartridge or tip of the bioinjection device ismodified to include multiple dispensing apertures. In this way,directional control for dispersing the medicament (e.g., autograft,allograft, BMP), or any other substance, is enhanced.

More particularly, as shown in FIGS. 11A and 11B, a tip 260 includesmultiple openings or apertures 262 located distally. However, it will beappreciated that the location of such apertures 262 can be anywherealong the tip. For instance, the apertures 262 can be located along thetip equal-distant about the circumference of the tip as shown in thecross-sectional view of FIG. 11B. In FIG. 11B, the tip can include fouropenings, one located on the front side 262 a of the tip, one located onthe back side 262 b of the tip, one located on the left side 262 c ofthe tip and one located on the right side 262 d of the tip. In anotherembodiment shown in FIG. 11C, two apertures 262 are located oppositeeach other along the circumference of the tip 260. In yet anotherembodiment, two or more apertures may be located any distance from eachother along the circumference of the tip. Still further, two or moreapertures 262 may be positioned on the same side of the tip 260 in astacked configuration. One embodiment shown in FIG. 11D includes twoapertures 262 located a certain distance around the circumference of thetip. The tip 260 may include a single aperture 262 as shown in FIG. 11E.Generally, the apertures 262 will have a diameter of 10 mm to 17 mm anda length of 5 mm; but any size diameter and/or length may be used.

It will be appreciated that any number of apertures, sizes, andlocations on the tip may be used. For example, FIG. 12A depicts anaperture 262 disposed near the middle of the length of the body of thetip 260. As another example, FIG. 13A depicts apertures 262 formed on adistal end 264 of one embodiment of tip 260. In addition, the apertures262 can take any shape such as, by way of example and not by limitation,oval, circular, square, rectangular, wavy, diamond and the like.Further, the apertures 262 can be the same shape or the apertures caneach have a distinct shape from one or more other apertures.

As shown in FIGS. 12A and 12B, included on the tip 260 may be a movabledirectional control member 266. This directional control member 266 isused to control dispersion of the medicament, or other substances, bycovering and closing off one or more of the apertures 262 of the tip260. This directional control member 266 may be made of any appropriatematerial, for instance, metal, polymers, acrylic, plastic, silicon,resins, or other substance. For example, by rotating the directionalcontrol member 266, the user can limit the dispersion of the medicament(and the amount thereof) towards a single direction to enhancedispersion of the medicament in that particular direction or anglewithin, by way of example only, a bone structure or other void as wellas discs, cartilage and other body tissues. FIGS. 12A and 12B show thedirectional control member 266 having an opening or slot 268 over theaperture 262 so that medicament would be allowed to exit the selectedaperture. In this embodiment, the directional control member 266 hasonly one opening or slot 268, but could have multiple openings or slots268 to allow medicament to exit multiple openings at once. The size ofthe slot 268 may vary in order to allow more than one aperture to beopen or to only allow a portion of one aperture to be open. It has alsobeen contemplated that the directional control member 266 may havemultiple slots positioned at any interval. FIG. 12C shows thedirectional control member 266 turned on the tip 260 such that theaperture 262 is blocked to prevent medicament from exiting the specificaperture 262. In one embodiment, an operator or user controls thedirectional control member by hand or otherwise manually moves thedirectional control member from a closed position to an open orpartially open position.

Another embodiment of a directional control member 267 having openings269 can be configured to allow dispersion of the medicament, or othersubstances, in more than one direction to enhance the dispersion of themedicament and/or substances. For example, the medicament can bedispersed from multiple apertures 262 as shown in FIG. 13A. As shown inFIG. 13B, the operator can turn the directional control member 267 toclose off all of the apertures 262. The directional control member 267can be designed such that one or more selected apertures are opened orpartially opened while other apertures remain closed. Again, thisprovides enhanced directional control over how and the amount of themedicament that the bioinjection device disperses from the tip 260.

In still another embodiment, as shown in FIGS. 14A and 14B, each tip 260includes a slidable member 270 that moves along a track 271 disposed onthe body of the tip 260. The slidable member 270 slides over theapertures 262 into an open or a closed position. In addition, theslidable member 270 can selectively move to variably control the size ofthe opening or aperture 262 to further enhance the direction and amountof dispersion of the medicament. As shown in FIG. 14C, the slidablemember 270 is positioned so that it covers only a portion of theaperture 262. It can be understood that the greater the size of theopening, the greater the dispersion amount. Still further, the user ofthe bioinjection device may operate the slidable member 270 anddirectional control members 266 and 267 manually and/or miniature motorsor other mechanisms may control the slidable and/or rotatable members.In short, it will be appreciated that the tip 260 can be configured withany number of apertures 262, in any number or combinations of locations,with each of the apertures having the same or different sizes and/orshapes.

In another embodiment as shown in FIG. 15A, each aperture 262 of the tip260 is initially sealed or closed to preclude any medicament from beingdispensed there-through. In this embodiment, one or more seals orsealing members 274, may be removed, perforated or otherwise opened asshown in FIG. 15B to allow the medicament to then be dispensed throughthe now open aperture(s) 262 while still precluding the dispensing ofmedicament from the remaining closed apertures. By way of example andnot by way of limitation, the seals that initially close the aperturesmay be formed of foil, plastic, polymers, acrylics, thin metal strips,silicon or any other suitable material. For example, in one embodiment,a foil or plastic membrane may cover an aperture. This membrane may becompletely removed by peeling it away from the tip and aperture.Alternatively, the membrane may be pierced to create multiple smallopenings or a single large opening therein to enable the medicament tobe dispensed. In short, any combination of techniques may be used toinitially seal the aperture and then to subsequently unseal the aperturefor controlling the direction and/or angle of medicament dispersion.

In still another embodiment, interchangeable preformed tips 260 can beused with the bioinjecting device. In this embodiment, each tip forms aunitary, closed structure, except for the direction or directions inwhich the medicament is to be dispensed. For example, the tip 260 canhave a single opening located anywhere along the circumference of thetip similar to the embodiment of the tip shown in FIG. 11E. Also, thetip 260 can have more than one opening therein to provide directionaldispersion over a broader array of directions, such as the embodimentsof tips shown in FIGS. 11B-11D. For example, tip openings or apertures262 can be employed on the back side and the right side simultaneouslyor the back side and the left side simultaneously, or in any othercombination of openings, to enhance the directional dispersion of themedicament. Again, the size, shape and orientation of the apertures canbe uniform or vary amongst the apertures.

The tips 260 described above can be used with another embodiment of abioinjection device 300. As shown in FIG. 16, device 300 is used todispense medicament stored in the tip 260 into a fracture, degenerativetissue, or the like of a spinal segment. The medicament, which may be abone morphologic protein, bone void filler, antibiotics, or the like,may be used for the healing of the spinal segment.

Bioinjection device 300 includes a housing 302 having a handle member304 and a trigger member 306. The housing 302 also includes a grip 308at a proximal end. An elongated tube 310 is mounted to the front(distal) end of housing 302, allowing for the dispensing of medicamentfrom the tips 260 where immediate proximity of the surgeon's hands isnot possible. The elongated tube 310 includes a proximal region 312 thatis preferably solid and relatively non-flexible and is joined to aflexible portion 314 at the distal end thereof. The flexible portion 314may be a coil or spring like structure. The flexible portion may assistthe user in reaching certain areas of the body that require treatment.For example, if the treatment area is in the superior tibia, theflexibility of the distal end of the bioinjection device allows accessbeyond the supra patellar tendon. A head 316 of the elongated tube 310is disposed distally to the flexible portion 314. In other embodiments,the head 316 is formed at the distal end of the flexible portion 314.Head 316 has an open outer end with internal threads formed therein. Inthis embodiment, the internal threads of the head 316 releasably attachto outer threads 317 formed on the tip 260. However, any means may beused to releasably attach the tip 260 to the bioinjection device 300,and further, the tip may be permanently attached to the bioinjectiondevice.

An inner shaft 318 extends through tube 310 as best shown in FIG. 17. Afront or distal end of the inner shaft 318 may include a blunt end 320.The shaft 318 may instead include a rounded or pointed end. The rear orproximal end of the inner shaft 318 is in connection with the triggermember 306. In one embodiment, the proximal end of the inner shaft 318is secured to a lever arm that is connected to the trigger member 306,similar to the structure shown in FIG. 2. Thus, rotation of triggermember 306 with respect to the handle member 304 drives forward slidingtranslation of the inner shaft 318 with respect to the elongated tube310; i.e., actuation of trigger member 306 causes forward sliding ofinner shaft 318 within the elongated tube 310.

When the trigger member 306 is not actuated, the blunt end 320 of theinner shaft 318 is positioned within the opening of the head 316. Oncethe trigger member 306 is actuated and the inner shaft 318 slidesforward, the blunt end 320 of the inner shaft moves forward or distal tothe head 316 and enters the cavity of the tip 260. As the blunt end 320continues to move forward, it engages and pushes a plunger 322 locatedwithin the tip 260. Pushing the plunger 322 of the tip 260 distallyforces medicament 324 stored within the tip 260 through the openaperture(s) 262.

It will also be appreciated that the medicament contained within thecartridges or tips 260 can be prepared and loaded either at a remotefacility or locally within the sterile field of an operating room or anyother procedure room or environment. When prepared locally, thephysician or someone under his control and direction may prepare themedicament cartridges or tips to meet the specific needs for the patientat the time of surgery or other procedures. This greatly enhances theflexibility and efficacy of this technology. Still further, it will beunderstood that persons other than physicians, including nurses,physician assistants or any other person required or needing to use thebioinjection device, may use the bioinjection device.

Furthermore, the various embodiments described above are provided by wayof illustration only and should not be construed to limit the invention.Those skilled in the art will readily recognize various modificationsand changes that may be made to the claimed invention without followingthe example embodiments and applications illustrated and describedherein, and without departing from the true spirit and scope of theclaimed invention, which is set forth in the following claims.

What is claimed:
 1. A bioinjection device, comprising: a housing havinga handle member and an elongated barrel connected to the handle member,the elongated barrel having a channel and a distal front end defining anopening; a trigger pivotally mounted on the housing; an inner shafthaving an end portion received within the channel of the elongatedbarrel, the inner shaft being slidable between a first position in whichthe end portion of the inner shaft is retracted within the elongatedbarrel and a second position in which the end portion of the inner shaftextends past the opening at the distal end of the elongated barrel; atip positioned at the most distal end of the bioinjection device, theentire tip removably attachable to the distal front end of the elongatedbarrel, the tip containing a medicament, the medicament being disposedin the most distal portion of the tip before use of the bioinjectiondevice, and the tip having an aperture for dispensing the medicamenttherethrough when the inner shaft is in the second position; and theaperture having an initial sealed state that is subsequently unsealableto control a direction of dispersion of the medicament.
 2. Thebioinjection device of claim 1, wherein the aperture has a diameterbetween 10 millimeters and 17 millimeters.
 3. The bioinjection device ofclaim 1, wherein the aperture is 5 millimeters in length.
 4. Thebioinjection device of claim 1, wherein the aperture is located alongthe tip equal-distant about the circumference of the tip.
 5. Thebioinjection device of claim 1, wherein the aperture is sealed using oneor more materials in the group comprising foil, plastic, silicon,polymers, acrylics, and metal strips.
 6. The bioinjection device ofclaim 1, wherein the aperture is selectively opened, perforated, orremoved to control the direction or angle of medicament dispersion. 7.The bioinjection device of claim 1, wherein the medicament includes oneor more from the group comprising autograft, allograft and BMP.
 8. Thebioinjection device of claim 1, further comprising a plurality ofapertures, wherein the plurality of apertures vary in size, one from theother.
 9. The bioinjection device of claim 1, further comprising aplurality of apertures, wherein the plurality of apertures vary inshape, one from the other.
 10. The bioinjection device of claim 1,further comprising a plurality of apertures, wherein the plurality ofapertures are all of the same shape.
 11. A bioinjection device,comprising: a housing having a handle member and an elongated barrelconnected to the handle member, the elongated barrel having a channeland a distal end defining an opening; a trigger pivotally mounted on thehousing; an inner shaft having an end portion, the inner shaft isreceived within the elongated barrel, the inner shaft being slidablealong the channel of the elongated barrel between a first position inwhich the end portion of the inner shaft is retracted within theelongated barrel and a second position in which the end portion of theinner shaft extends past the opening at the distal end of the elongatedbarrel; a tip positioned at the most distal end of the bioinjectiondevice, the entire tip removably attachable to the distal end of theelongated barrel, the tip containing a medicament, the medicament beingdisposed in the most distal portion of the tip before use of thebioinjection device, the tip including an aperture for dispensing themedicament; a directional control member that is operative toselectively control the amount of dispersion of medicament from each ofthe plurality of tip apertures; and an actuation mechanism coupling thetrigger with the inner shaft.
 12. The bioinjection device of claim 11,wherein the directional control member is rotatable to close at leastone aperture while leaving at least another one aperture in an openposition for dispensing the medicament.
 13. The bioinjection device ofclaim 11, wherein the directional control member is used to control thelocation or angle of dispersion of the medicament.
 14. The bioinjectiondevice of claim 11, wherein the tip includes a plurality of aperturesfor dispensing medicament.
 15. The bioinjection device of claim 14,wherein the apertures are located along the tip equal-distant about thecircumference of the tip.
 16. The bioinjection device of claim 11,wherein the aperture has a diameter between 10 millimeters and 17millimeters.
 17. The bioinjection device of claim 11, wherein theaperture is 5 millimeters in length.
 18. The bioinjection device ofclaim 11, wherein the medicament can be prepared to a desiredspecification during a procedure.
 19. The bioinjection device of claim11, wherein the medicament is comprised of one or more from the groupcomprising autograft, allograft and BMP.